International. Facility Explorer's validated environments module enables system users to comply with FDA 21 CFR Part 11 procedures and standards.
The Validated Environments module of Facility Explorer allows to add new additional programmable functions to the control system, allowing that in case of any change in a control point under the validated environments module, the validation of the change by a user with administrative permissions defined in the same module is necessary.
Among other functions, the module allows the recording of historical data protected by validation, the recording of time series according to the 21CFR part 11 standard and the electronic signature.
In addition, the use of the validated environments module will allow compliance with the necessary procedures and controls MOP (conforming procedure method) and POE (Standard Operating Process).
Key advantages
- Convert a new or existing FX80 supervisor station to an FX80 station for validated environments, or use the FX Server as a server for validated environments.
- Protect your historical and audit information through the validation module.
- Designate new and existing points to use within the validated environment, non-critical points can remain as standard points within Facility Explorer.
- Manage points through the new fields: Emergency Cancellation, Automatic Emergency, Auto Mode, Active and Inactive Emergency (All with authentication).
- Configure clients, categories, roles, and users.
Server-level licensing
Integrate different devices and controllers through IP communication protocols, to convert the information of those equipment into control points validated under the License of Validated Environments of Facility Explorer.
FX80-level licensing
Integrate different devices and controllers through IP communication protocols or protocols derived from the RS485 standard, to convert the information of those equipment into control points validated under the Facility Explorer validated environments license.
In case of using multiple FX80 supervisors with validated points, each of the supervisors must be validated under the validated environments module.
Validate checkpoints with up to two different levels of electronic signature using Facility Explorer's validated environments module.
